Biologisk värdering av medicintekniska produkter

Kommittébeteckning: SIS/TK 340/AG 02 (Biologisk säkerhet)
Källa: CEN
Svarsdatum: den 23 jul 2024
Se merSe mindre
 
Kommittébeteckning: SIS/TK 340/AG 02 (Biologisk säkerhet)
Källa: CEN
Svarsdatum: den 19 aug 2024
Se merSe mindre
 

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.